To shed light on these underregulated drugmakers, More decided to test the quality of the bioidentical hormones they produce. We asked Flora Research Laboratories in Grants Pass, Oregon, which specializes in -natural-products research, to evaluate 12 prescriptions we collected from compounders throughout the U.S. Flora’s analysis revealed that these hormones are of unreliable potency and that they would not come close to meeting the FDA’s requirements for commercially manufactured drugs. Doses in the pills we tested fluctuated in a way that could increase the risk of uterine cancer because of a shortfall of the hormone progesterone. (For details of Flora’s methodology, see “How the Drugs Were Tested,” below.)
“More’s testing suggests that women are wasting their money on hormone treatments that may not be effective and might put their health at risk,” concludes Bruce Bouts, MD, RPh, a Findlay, Ohio, internist who was one of the first physicians to bring compounding pharmacies to the attention of the FDA and the Ohio state pharmacy board. Notes Margery Gass, MD, executive director of the North American Menopause Society and a consultant at the Cleveland Clinic Center for Specialized Women’s Health: “The research by More indicates that women are taking a gamble when they purchase compounded estrogen and progesterone.” Why, then, are these drugs more popular than ever? Here’s what More found.
What makes bioidenticals so appealing
Prempro, a combination of conjugated equine estrogen (synthesized from pregnant mares’ urine) and a synthetic progestin called medroxyprogesterone, used to be the best-selling commercial hormone therapy; it offered an effective way to relieve much of the discomfort of menopause. But in 2002, Prempro, the only drug used in one arm of the large-scale Women’s Health Initiative (WHI), was linked with serious medical problems—such as an increased risk of heart attack, stroke, blood clots and invasive breast cancer. Faced with such alarming results, many doctors told patients who were already using hormone therapy to give it up, and they advised younger women just entering the menopausal transition to forget about HT. Sales of Prempro and similar drugs plummeted. From 2001 to 2008, the number of adult women filling one or more commercial HT prescriptions annually fell, from 17.9 million to 5.8 million, a decrease of 68 percent.
Perimenopausal and postmenopausal women still experienced disruptive symptoms and still needed relief. Consequently, in 2002, bio-identical hormones, marketed as safer than commercial HT products because they were more natural, started to take off.
Bioidentical estrogen and progesterone are made from diosgenin, a plant-derived sterol found in wild yams, and are identical in molecular structure to hormones produced in a woman’s body. Bioidentical estrogen is believed to fit into the body’s estrogen receptors perfectly, without causing the bio-chemical disturbance sometimes created by the conjugated equine estrogen used in commercially formulated HT, which is a less perfect molecular match. A similar situation exists with bioidentical progesterone. However, researchers have not published a head-to-head comparison of bioidenticals and conventional HT in terms of risks for stroke, cancer and other illnesses. At this point, the safety advantages of BHT are only hypothetical.
Nor is it accurate to say that compounded bioidenticals are more natural than those in FDA-approved commercial HT formulations; both are heavily synthesized products. You can’t simply pluck a yam from the dirt, cut it open and rub it on your skin; the manufacture of bioidenticals involves multiple levels of processing in a sophisticated laboratory. A better name for such products would be bio-available hormones (since the sterol is available in plants), or plant-derived sterol hormones. But the term bio-identical has the appeal of sounding completely safe, so it stuck.